Benefix™ Interspinous Fixation System

FDA UDI

Class II (US FDA UDI)

by CG MedTech Co., Ltd.

Identity

Trade Name: Benefix™ Interspinous Fixation System FDA UDI
Generic Name: Interspinous spinal fixation implant FDA UDI
Model / Reference: IS11223 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800015918305 FDA UDI
FDA Product Code: PEK FDA UDI
GMDN Term: Interspinous spinal fixation implant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Interspinous spinal fixation implant

Benefix™ Interspinous Fixation System by CG MedTech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interspinous spinal fixation implant.

Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
InSpan® — SPINEFRONTIER, INC. · Class II
StabiLink®MIS Spinal Fixation System — Southern Spine LLC · Class II
restor3d Lumbar Implant — Restor3D · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: CG MedTech Co., Ltd.

Sources (1)

FDA UDI b4d0884a-de54-46c1-8320-f7a08d931210 33 fields · synced Jun 8, 2026